Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm.
The patient has had catamenial seizures affecting her right arm since age fifteen.
She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6).
It was reported that vns has "reduced her seizures from daily to only associated with menses.
" the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures.
The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses.
However prior to vns, she had them outside her menses as well.
The patient experiences multiple focal seizures around her menses.
The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest.
However, palpation does not recreate pain, rather, the pain is created by stretching.
The patient takes hydrocodone and ibuprofen for the left chest pain.
The patient was concerned that vns may be causing the pain.
Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns.
The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken.
" the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand.
The patient wanted to know what to do because the pain was progressing.
The patient was referred for a stat chest x-ray to check the leads.
However, no lead breaks were noticed by the physician during a review of the x-rays.
The patient was prescribed percocet.
The patient was also referred for a consult with a surgeon for a new generator or vns adjustment.
The x-rays were not sent to the manufacturer for analysis.
The patient had generator replacement surgery on (b)(6) 2011.
Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far.
The reason for generator replacement is not known at this time.
The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction.
A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3.
91 years until eri=yes.